JOB DESCRIPTION 29/12/2015 REGULATORY AFFAIRS INTERN
Code: Regulatory Affairs Intern
1 – MEDINCELL WEBSITE CATCH PHRASE
Are you ready to work in a fast-changing environment where your initiative is valued? Would you like to have the opportunity for rapid professional development? Do you want to contribute to a new pharmaceutical model, which puts people (patients, employees, partners) in the center of all its efforts? Would you like to be part of a self-funded biotech start-up owned by its motivated and creative employees? If so, then let us know. You may be our next Regulatory Affairs Intern!
2 - MEDINCELL SUMMARY We are seeking a Regulatory Affairs Intern in our Montpellier (Jacou) facility to participate in our ongoing success as a profitable, fast-growing, socially responsible biotech.
3 - SUMMARY
Team interactions: The Regulatory Affairs Intern will evaluate the competitors of Medincell and its Bepo delivery platform. He/she will also help the regulatory affairs specialist in regulatory watching, supporting early development regulatory activities, updating the planning models and project management for tracking regulatory activities and evaluating the relevant regulatory pathways for new drug delivery technologies to support the company’s strategy.
4 - POSITION ASSIGNMENTS
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Become familiar with excipient and novel excipient regulation in the UE and the US Become familiar with typical regulatory pathway for known API Benchmark regulatory pathway used to register SuperGenerics Compile the regulatory feedback from international agencies on Bepo technology Implement internal regulatory SOPs Regulatory watch Implement GMP rules and control of the supply chain management for excipients Help in reporting needs Implement tracking tools for planning activities with project managers
1 AVENUE CHARLES CROS - 34830 JACOU - FRANCE I TEL. : +33 (0) 4 67 41 99 74 I FAX : +33 (0) 4 67 02 13 67 SAS AU CAPITAL DE 151.322,50 € I RCS MONTPELLIER B 444 606 750 I TVA INTRA. : FR 34444606750 I WWW.MEDINCELL.COM
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